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HomeU.S. FDA Guidance › U.S. FDA Drug Definitions

U.S. FDA Drug Definitions


The U.S. FDA has helped define various terms in the drug industry:
  • Active Ingredient: Any component of a drug product intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans or other animals. Active ingredients include those components of the product that may undergo chemical change during the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect.

  • Active Pharmaceutical Ingredient: Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or function of the body. Reference: Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients FDA Guidance

  • API Starting Material: A raw material, intermediate, or an API that is used in the production of an API and that is incorporated as a significant structural fragment into the structure of the API. An API Starting Material can be an article of commerce, a material purchased from one or more suppliers under contract or commercial agreement, or produced in-house. API Starting Materials are normally of defined chemical properties and structure. Reference: Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients FDA Guidance

  • Bulk Drug Substance: According to 21CFR207.3(a)(4) means any substance that is represented for use in a drug and that, when used in the manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug, but the term does not include intermediates used in the synthesis of such substances.

  • Drug Product: A finished dosage form, for example, a tablet, capsule or solution that contains an active pharmaceutical ingredient, generally, but not necessarily, in association with inactive ingredients. Reference: Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients FDA Guidance

  • Drug Substance: See "Active Pharmaceutical Ingredient"

  • Excipients: Examples of excipients include fillers, extenders, diluents, wetting agents, solvents, emulsifiers, preservatives, flavors, absorption enhancers, sustained-release matrices, and coloring agents.

  • Formulations: Pharmaceutical formulation, is the process in which different chemical substances, including the active drug, are combined to produce a final medicinal product.

  • Homeopathy: The practice of treating the syndromes and conditions which constitute disease with remedies that have produced similar syndromes and conditions in healthy subjects.

  • Homeopathic Drug: Any drug labeled as being homeopathic which is listed in the Homeopathic Pharmacopeia of the United States (HPUS), an addendum to it, or its supplements.

  • Homeotherapeutics: Involves therapy which utilizes drugs that are selected and administered in accordance with the tenets of homeopathy.

  • Homeopathic Pharmacopeia of the United States (HPUS): A compilation of standards for source, composition, and preparation of homeopathic drugs. HPUS contains monographs of drug ingredients used in homeopathic treatment. It is recognized as an official compendium under Section 201(j) of the Act.

  • Inactive Ingredient: According to 21 CFR 210.3(b)(8), an inactive ingredient is any component of a drug product other than the active ingredient. Only inactive ingredients in the final dosage forms of drug products are in this database.

  • Intermediate: A material produced during steps in the synthesis of an API that must undergo further molecular change or processing before it becomes an API. Reference: Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients FDA Guidance

  • Material: A general term used to denote raw materials (starting materials, reagents, solvents), process aids, intermediates, APIs, and packaging and labeling materials.
  • Over-the-Counter Drug: A human drug that is safe and effective for use without prescription by a licensed medical practitioner.

  • Prescription Drug: A human drug that is not safe for use except under the supervision of licensed medical practitioner.

  • Starting Material: See "API Starting Material"



 






























































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